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Is Belimumab Effective?The NICE Decision
By A. G. Moore 8/2/2013

Monoclonal antibodies for cancer. Photo derived from CDC by Ch1902 vector
From Wikipedia, Public Domain

In answer to the question at the top of
this article--I'm not qualified to say. Last weekNICE,
the body in
the UK which sets treatment guidelines for the NHS,
rejected belimumab for lupus treatment; the agency said the medicine simply was not
effective
enough to justify its cost. Meanwhile, in 2011 the US FDA approved the
drug's use and the US government, through Medicare, pays for it. The
FDA's approval comes with a strict recommendation about the way
belimumab should be used: it is to be prescribed only as an adjunct
therapy and only for a specific subset of lupus patients.

As the contrast between the FDA's
approval and NICE's rejection reflects, there is not unanimous agreement about the effectiveness of belimumab (marketed by SmithGlaxoKline as Benlysta).

According to an article published by
the journal Prescrire in June
of 2013, high expectations for belimumab have not produced good results.Authors of the Prescrire article conclude that belimumab isn't worth the money it costs; not only that, the authors go on to assert that using the drug isn't in the
best interest of patients. The Prescrire article states:"...belimumab add-on therapy simply
complicates the treatment of systemic lupus erythematosus and should
not be used".
The journal cites, in support of its conclusion, an increased risk of immunosuppression and a lack of
demonstrated efficacy in clinical trials after the 76th week of
belimumab treatment.

On the
other hand, another respected journal,ARD,
reports that quality of life measures for patients on belimumab therapy
improved over a trial period of 52 weeks and that measures of mental
competency continued to reflect improvements at the end of 76 weeks.
The authors of this article conclude that use of belimumab as an
add-on therapy results in "...reductions in disease
activity".

So what are we,
consumers of medicine and lupus patients, to make of contradictory
trial results and conflicting government assessments? I think we
have to first of all keep in mind that if we are sick enough to be
considered for belimumab therapy, then we should talk to
our doctors and ask them about the research they have read and how this
research has prompted them to recommend the drug. Then we should go to
the
journals and satisfy ourselves about the appropriateness of this
treatment in our particular case.

Sometimes, there
are
no good choices. Sometimes, we roll the dice and hope a long
shot works. But we should know, if possible, the relative odds; we
should be informed about risks and benefits. When it comes to
belimumab, there is controversy. Knowing that, we make an informed
decision about whether or not to go forward with treatment.

More articles on belimumab are
listed below. One thing that should be checked out
is conflict of interest statements; if a trial is funded by
GlaxoSmithKline or an affiliate, then there might be an unconscious bias
toward positive results. If you are contemplating taking
belimumab, go way beyond the articles mentioned here. There's a lot of
material available and you should sample a good portion of it.